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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nametester, pacemaker electrode function
Generic Nametester, pacemaker electrode function
Regulation Number870.3720
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS003
Date Received11/02/1999
Decision Date05/01/2000
Product Code
DTA[ Registered Establishments with DTA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) the introduction of patient data manager softward, pdm 2000, and 2) a new method for determining the use before date of biotronik's icds.
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